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European Medicines Agency review of ixazomib (Ninlaro) for the treatment of adult patients with multiple myeloma who have received at least one prior therapy
  1. kyriaki Tzogani1,
  2. Beatriz Florez2,
  3. Greg Markey2,
  4. Mariapaola Caleno3,
  5. Odoardo Maria Olimpieri3,
  6. Daniela Melchiorri4,
  7. Doris Johanna Hovgaard5,
  8. Sinan Bardakci Sarac5,
  9. Karri Penttilä6,
  10. Tuomo Lapveteläinen6,
  11. Tomas Salmonson7,
  12. Jonas Bergh8,
  13. Christian Gisselbrecht9,
  14. Francesco Pignatti1
  1. 1European Medicines Agency, Amsterdam, The Netherlands
  2. 2MHRA, London, UK
  3. 3AIFA, Roma, Italy
  4. 4Dip. Physiology and Pharmacology, V. Erspamer, University of Rome La Sapienza, Roma, Italy
  5. 5Laegemiddelstyrelsen, Kobenhavn, Denmark
  6. 6Finnish Medicines Agency Fimea, Helsinki, Finland
  7. 7Lakemedelsverket, Uppsala, Sweden
  8. 8Radiumhemmet Microbiology and Tumorbiology Center, Karolinska University Hospital, Stockholm, Sweden
  9. 9Institut d'Hématologie, Hôpital Saint Louis Paris Diderot Université, Hospital Saint-Louis, Paris, France
  1. Correspondence to kyriaki Tzogani; kyriaki.tzogani{at}ema.europa.eu

Footnotes

  • Contributors Data analysis and interpretation: BF, GM, MC, OO, DM, Dh, SBS, KP, TL. Manuscript writing: KT, BF, GM, MC, OO, DM, DH, SBS, KP, TL, FP. Final approval of manuscript: KT, BF, GM, MC, OO, DM, DH, SBS, KP, TL, TS, JB, CG, FP.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Disclaimer This publication is based on the scientific review of the application leading to approval of ixazomib in the EU. The detailed scientific assessment report and product information for this product are available on the European Medicines Agency website (http://www.ema.europa.eu). The authors of this paper remain solely responsible for the opinions expressed in this publication.

  • Competing interests Jonas Bergh:Research grants for academic clinical studies/ molecular marker spin-off to Karolinska University Hospital and/or Karolinska Institutet from Amgen, AstraZeneca, Bayer, Merck, Pfizer, Roche and Sanofi Aventis, no personal payments.Honoraria from UpToDate for the chapter on “Prognostic and Therapy Predictive factors" for early breast cancer to Asklepios Medicin HB.

  • Patient consent for publication Not required.

  • Provenance and peer review Commissioned; internally peer reviewed.

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Footnotes

  • Contributors Data analysis and interpretation: BF, GM, MC, OO, DM, Dh, SBS, KP, TL. Manuscript writing: KT, BF, GM, MC, OO, DM, DH, SBS, KP, TL, FP. Final approval of manuscript: KT, BF, GM, MC, OO, DM, DH, SBS, KP, TL, TS, JB, CG, FP.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Disclaimer This publication is based on the scientific review of the application leading to approval of ixazomib in the EU. The detailed scientific assessment report and product information for this product are available on the European Medicines Agency website (http://www.ema.europa.eu). The authors of this paper remain solely responsible for the opinions expressed in this publication.

  • Competing interests Jonas Bergh:Research grants for academic clinical studies/ molecular marker spin-off to Karolinska University Hospital and/or Karolinska Institutet from Amgen, AstraZeneca, Bayer, Merck, Pfizer, Roche and Sanofi Aventis, no personal payments.Honoraria from UpToDate for the chapter on “Prognostic and Therapy Predictive factors" for early breast cancer to Asklepios Medicin HB.

  • Patient consent for publication Not required.

  • Provenance and peer review Commissioned; internally peer reviewed.

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